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FDA 510(k)

SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030

K-Number: K915768 · 1992-02-11

ApplicantSurgical Laser Products, Inc.
Decision Date1992-02-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030 is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Laser Products, Inc.. It received FDA 510(k) clearance on 1992-02-11 under 510(k) number K915768. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030?

SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030 is a medical device that received FDA 510(k) clearance on 1992-02-11. The listed applicant is Surgical Laser Products, Inc.. The 510(k) number is K915768.

When did SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030 receive FDA 510(k) clearance?

SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030 received FDA 510(k) clearance on 1992-02-11, under 510(k) number K915768.

Who is the listed applicant for SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030?

The FDA 510(k) record lists Surgical Laser Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030?

The FDA product code for SURGI LIGHT ND:YAG LASER SYSTEM MODEL 904030 is GEX. This falls under the Gastroenterology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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